Asco 2021 – Keytruda’s adjuvant kidney win is the real deal
Those fretting about the magnitude of Keytruda’s disease-free survival win in Keynote-564, the first positive phase 3 trial of an adjuvant immunotherapy in renal cancer, need not have worried. The study’s just unveiled Asco late-breaker has shown a 32% reduction in risk of disease progression versus placebo (p=0.0010), the likely approvable primary endpoint. Just as important is the secondary endpoint of overall survival, which is showing a 46% reduction in risk of death. True, at p=0.0164 this was not statistically significant – but this was a result of a high bar set at this early interim analysis, corresponding to a December 14, 2020 cutoff. In reality, the strong hint is that Keytruda really is helping renal cancer patients live longer when given as adjuvant for a year within 12 weeks of surgery. The results further underscore the Merck & Co drug’s widening lead against its kidney cancer rivals, in particular Opdivo, though it should be stressed that competitor phase 3 adjuvant studies are under way and start reading out next year.